Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional MRI with gadolinium injection and 3D camera imaging.
- Who it may be relevant to
- Registry conditions: Subclinical Breast Cancer Lesion. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Breast cancer is diagnosed by imaging at a non-palpable stage in more than half of all cases. Surgical removal requires preoperative guidance. Generally, preoperative guidance is performed using a metal guide under local anaesthetic and radiological control. This type of guidance has several limitations. For the patient, it can be painful and traumatic. The procedure involves two departments: radiology and the operating theatre, which poses logistical constraints. What's more, between 10% and 40% of patients require repeat surgery for unhealthy margins, raising the question of the effectiveness of the tracking procedure. The investigators propose to develop a non-invasive intraoperative guidance system: Augmented Reality, which will provide a 3D vision with virtual transparency of the breast during surgery, thanks to real-time fusion of preoperative imaging with video from a camera located in the operating room. The process is illustrated below. Illustration of the general principle of the augmented reality system for locating non-palpable breast lesions. The images above represent a preliminary test carried out on the computer outside the operating room. This is an initial research prototype which has not yet been validated and is not suitable for routine use.
Interventions
- Procedure Additional MRI with gadolinium injection and 3D camera imaging
The study includes an additional MRI with gadolinium injection, performed in addition to standard practice. In addition, 3D camera images will be acquired at the time of surgery.
Primary outcome measures
- Feasibility of the study [Time frame: 1 year]
Secondary outcome measures (3)
- Time measurement of the study procedure [Time frame: 1 year]
- Creating a phantom [Time frame: 1 year]
- Assessment of the feasibility of images fusion [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Major women
- Requiring conservative surgical management of a subclinical cancerous breast lesion (not palpable), the histology of which has been previously proven by anatomopathology;
- Having a breast MRI indication at the time of the breast assessment performed at the Centre Jean Perrin
- Ability to give informed consent to participate in the study,
- Membership of a social security scheme
Exclusion criteria
- Patients with breast neoplasia during pregnancy;
- Persons deprived of their liberty or under guardianship or incapable of giving consent;
- Refusal to participate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Centre Jean PERRIN — Clermont-Ferrand
Identifiers
NCT: NCT06512558 · 2023-A02648-37